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Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients

Primary Purpose

ARDS, COVID-19, Mechanical Ventilation Pressure High

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual loading of the chest wall
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ARDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Non-surgical patients admitted to the ICU at Regions Hospital (St. Paul, MN) or Methodist Hospital (St. Louis Park, MN), receiving mechanical ventilation for any reason, and breathe passively during mechanical ventilation Exclusion Criteria: Age < 18 years old Pregnancy at the time of their inclusionary hospitalization Recent (< 30 days) abdominal or chest wall surgery (including spine) Recent (< 30 days) abdominal or chest wall trauma (including spine) Traumatic brain injury, intracranial bleed, or recent neurologic surgery Family member or representative not available to provide informed consent Not passive while receiving mechanical ventilation support Hemodynamic instability

Sites / Locations

  • Regions Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chest wall loading

Arm Description

All patients who are receiving mechanical ventilation and are passive on the ventilator will have chest wall loading performed to identify whether there is a paradoxical decrease in lung compliance.

Outcomes

Primary Outcome Measures

Lung compliance (mL/mmHg)
Does lung compliance improve (ie, increase) with an intervention (chest wall loading) that decreases chest wall compliance/reduces lung volume.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2021
Last Updated
October 23, 2023
Sponsor
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06093958
Brief Title
Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients
Official Title
Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients: Incidence, Mechanism, and Novel Techniques for Detecting it at the Bedside
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Administratively closed by IRB after continuing review was never submitted and no patients enrolled.
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mechanical ventilation can be a life-saving intervention for patients with respiratory failure, but the acutely injured lung is vulnerable to further damage if positive pressure ventilation is not employed judiciously. "Lung protective ventilation" encompasses a group of practices intended to minimize ventilator-induced lung injury (VILI) and includes the delivery of low tidal volumes (to minimize dynamic lung strain) and the prevention of injuriously high airway pressures (to minimize lung stress). The prone position, which compresses (or "loads") the chest wall, more evenly distributes volume and pressure, mitigates the damaging effects of stress/strain, and improves clinical outcomes in patients with severe respiratory failure from adult respiratory distress syndrome (ARDS). Chest wall loading would not be expected to produce these beneficial effects in the supine position-quite the opposite; it usually results in net volume loss and higher airway pressures in response to an unchanging tidal volume. A paradoxical response to chest wall loading, leading to decreased airway pressures, however, was recently reported in a group of patients with advanced lung disease secondary to COVID-19. In this cohort, a paradoxical decrease in airway pressures was elicited during a brief period of manual compression of the abdomen. This maneuver, which is non-invasive, free of cost, and gives real-time information, may have important diagnostic (and potentially therapeutic) implications for ventilator management in patients with respiratory failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, COVID-19, Mechanical Ventilation Pressure High, Ventilator-Induced Lung Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chest wall loading
Arm Type
Experimental
Arm Description
All patients who are receiving mechanical ventilation and are passive on the ventilator will have chest wall loading performed to identify whether there is a paradoxical decrease in lung compliance.
Intervention Type
Diagnostic Test
Intervention Name(s)
Manual loading of the chest wall
Intervention Description
The chest wall will be loaded by either compression of the abdominal wall, compression of the lumbar spine, or compression of the sternum.
Primary Outcome Measure Information:
Title
Lung compliance (mL/mmHg)
Description
Does lung compliance improve (ie, increase) with an intervention (chest wall loading) that decreases chest wall compliance/reduces lung volume.
Time Frame
20 minutes total in measure duration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-surgical patients admitted to the ICU at Regions Hospital (St. Paul, MN) or Methodist Hospital (St. Louis Park, MN), receiving mechanical ventilation for any reason, and breathe passively during mechanical ventilation Exclusion Criteria: Age < 18 years old Pregnancy at the time of their inclusionary hospitalization Recent (< 30 days) abdominal or chest wall surgery (including spine) Recent (< 30 days) abdominal or chest wall trauma (including spine) Traumatic brain injury, intracranial bleed, or recent neurologic surgery Family member or representative not available to provide informed consent Not passive while receiving mechanical ventilation support Hemodynamic instability
Facility Information:
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study did not enroll any participants so there is no IPD to be shared.

Learn more about this trial

Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients

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